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伊马替尼为CKIT突变的转移性黑色素瘤患者带来希望
2011-06-30 本站编辑上一篇 | 下一篇


                  From Reuters Health Information
    Imatinib Effective for Metastatic Melanoma With C-Kit Mutation
                        BY Will Boggs MD

     

    NEW YORK (Reuters Health) Jun 22 - Imatinib mesylate offers hope for patients with metastatic melanoma harboring c-Kit mutations, Chinese researchers report.
    "Before this JCO paper we published, there were three investigator initiated trials which used imatinib for unselected melanoma patients," Dr. Jun Guo from Peking University Cancer Hospital and Institute, Beijing, told Reuters Health by email.
    In those trials there was only one objective response noted, Dr Jun Guo continued, and this was a patient with acral melanoma who had a c-Kit mutation. In the new phase II trial by Dr. Guo and colleagues, in which all patients harbored c-Kit mutations, there was a 54% disease control rate with imatinib, demonstrating the importance of patient selection.
    Dr. Guo and colleagues evaluated progression-free survival, overall response rates, and overall survival in a phase II trial of imatinib in 43 patients with metastatic melanoma harboring c-Kit mutations and/or amplification of c-Kit gene copy number.
    The 6-month progression-free survival rate was 36.6%, and the median progression-free survival was 3.5 months. Median progression-free survival was longer (albeit insignificantly) in patients harboring exon 11 or 13 mutations than in those harboring other aberrations but similar in patients with single and multiple aberrations.
    Ten patients (23.3%) achieved partial responses, 13 patients (30.2%) had stable disease, and 20 patients (46.5%) had progressive disease, according to a June 20th online paper in the Journal of Clinical Oncology.
    Over half the patients (53.5%) had early disease control (partial response plus stable disease), and 18 patients (41.9%) showed regression of tumor mass.
    These results are "promising compared with largely ineffective therapies evaluated in patients without a definable predictive biomarker," the researchers note.
    The one-year overall survival rate was 51.0%, and the median overall survival was 14.0 months. Overall survival was 15 months in patients who achieved a partial response or stable disease, compared to nine months in patients with disease progression (P=0.036).
    Adverse events were generally of mild to moderate severity and easily managed by dose reduction, dose interruption, or supportive medical treatment, although toxicity was generally intolerable in the 15 patients who were allowed to escalate their daily imatinib dose from 400 to 800 mg.
    "For these patients, most of them with stage IV disease and failed with chemotherapy, there are no standard treatments," Dr. Guo said.
    "As we can imagine in the future, maybe we can distinguish melanoma patients into several groups," Dr. Guo said. For instance, patients with the Bref mutation could use PLX4032, and patients with c-Kit can use imatinib.
    The study was supported by a grant from Novartis Oncology in China. One of the 21 authors received research funding from Novartis.
    SOURCE: http://www.medscape.com/viewarticle/745103


    纽约(路透社健康专栏)6月22日讯 (作者:Will Boggs)
    伊马替尼为CKIT突变的转移性黑色素瘤患者带来希望----来自中国学者的报道
     
    来自北京大学肿瘤医院暨北京肿瘤研究所的郭军医生,近日接受了路透社健康专栏的采访,并说到:“在我们发表的这篇JCO文章之前,有3个研究者发起的临床研究使用伊马替尼治疗晚期黑色素瘤患者,但是没有对患者进行基因变异检测来选择适合治疗的患者” ,“结果这几个临床研究中仅有1例患者有客观疗效,最近证实这例有效的患者为含CKIT突变的肢端黑色素瘤”。在这项由郭军医生及其团队开展的新的II期临床研究中入组的全是CKIT突变的患者,最后获得了54%的疾病控制,说明了患者选择的重要性。
    郭军医生及其团队在该项II期临床研究中评价了43例患者(均为CKIT基因突变或扩增的转移性黑色素瘤患者)总体的PFS(无疾病进展生存),ORR(总反应率)和OS(总生存),该结果已在JCO杂志的6月20日正式发表:6个月的PFS率为36.6%,中位PFS为3.5个月。相比其他外显子突变的患者,11号或13号外显子突变患者的中位PFS更长,另外多发CKIT变异的患者较单发的PFS长(均无统计学差异)。10例患者(23.3%)获得PR(部分缓解),13例患者(30.2%)获得SD(疾病稳定),20例患者PD(疾病进展)。
    郭军医生还强调,“与目前大部分治疗缺乏明确预测疗效的因子相比,本项研究还是非常有希望的:1年生存率达到了51.0%,中位OS达到了14月; 并且获得PR或SD患者的OS为15个月,与疾病进展的患者相比,有明显的统计学意义(P=0.036)。副反应为中到轻度,经过药物减量、短暂停药或药物治疗后可恢复,但是对于15例增量至600或800mg的患者来说,药物副反应则难以耐受。”.
    郭医生又谈到:“对于这些患者,大部分为经过化疗失败的IV期患者,没有标准的治疗方案,或许将来黑色素瘤的治疗,我们可以将患者分为几大类,存在BRAF突变的患者可以使用PLX4032,存在CKIT的患者可以使用伊马替尼”。
     
    该研究受中国诺华肿瘤部的基金赞助,21位作者中一位获得诺华的研究基金资助。